Diagnosing Ovarian Cysts - the DOC Study

NCT04188652 | Completed DMC

• 1 other identifier: The DOC study
• Study Type: observational
• Target: 1,123
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Ovarian cysts are common in women. The vast majority is benign; yet, ovarian cancer (OC) is seen in 500 women every year in Denmark. OC is often diagnosed in advanced stages, and OC is the fifth most deadly cancer in women in more developed countries. It can be a clinical challenge to distinguish benign ovarian cysts from OC. Currently, the Risk of Malignancy Index (RMI) is used to detect women at high risk of OC in Denmark, however, new methods to correctly differentiate benign ovarian cysts from OC at an early stage is needed. New promising studies suggest an improved diagnostic accuracy by adding the biomarker Human Epididymis Protein 4 (HE4) and systemized ultrasound imaging International Ovarian Tumor Analysis (IOTA). Purpose: The purpose is to evaluate the diagnostic performance of HE4 and IOTA in a Danish clinical setting. Furthermore, to develop an optimized diagnostic algorithm to differentiate ovarian cysts based on a combination of symptoms, biomarkers and IOTA. Methods: The study is a prospective, observational study. Women with ovarian cysts are included from gynecological practitioners and departments in the Capital Region of Denmark. Detailed information on health and symptoms are registered, and the cysts are systematically described by the gynecologist in accordance to the IOTA terminology. HE4 will be analyzed in those women who routinely needs a diagnostic blood test for CA125. Data will be coupled with data from the patient file and Danish Gynecological Cancer Database (DGCD). The diagnostic utility of HE4 and IOTA will be evaluated both alone and in combinations with health information, symptoms, and CA125. The study has been approved by the Regional Committee on Health Research Ethics (H-19021342) and the Data Protection Agency (P-2019-340). Significance: This study establishes a unique database which will form the basis for developing an optimized method for differentiating ovarian cysts, and thus optimize referral and diagnosis.

Conditions

Ovarian Cysts; Ovarian Cancer; Ovarian Neoplasms; Ovarian Cancer Stage

Keywords

Ultrasound in accordance to IOTA; Symptoms and healthdata in women with ovarian cysts; HE4 measured in women with ovarian cysts

Outcome Measures

Primary Outcomes (3)

• Number of women with benign ovarian disease, borderline ovarian tumors, and ovarian cancer

  Histology of ovarian cysts

  Assessed regularly through study inclusion period in a total period of 2,5-3 years

• FIGO stage of ovarian cancer

  FIGO stage of ovarian cancer

  Assessed regularly through study inclusion period in a total period of 2,5-3 years

• Diagnostic utility of HE4, CPH-I and IOTA in differentiating ovarian cysts

  The diagnostic accuracy (SN, SP, PPV, NPV, AUC) of HE4, CPH-I, and IOTA to determinie ability to differentiate healthy women, women with non-gynecologic disease, benign gynecologic disease, borderline ovarian tumors, and OC will be examined using univariate and multivariate logistic regression analyses. Diagnostic utility of HE4, CPH-I and IOTA will be compared to CA125, ROMA and RMI.

  Assesed after study inclusion and data collection after 3 years.

Interventions

Detailed symptomregistration OTHER

Information on symptoms, specialized ultrasound in accordance to IOTA, and HE4 is registered in women with ovarian cysts. Participation in the study including symptom registration, description of the cyst using IOTA terminology, and HE4 determination will not affect further diagnostics or treatment. HE4 will not be informed to the patient or clinician.

Also known as: Human Epididymis protein 4 (HE4), Internation Ovarian Tumor Analysis (IOTA)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study is a prospective, observational study. After oral and written project information and consent is given, women are included by gynecologist from a gynecology practice or a department of gynecology in the Capital Region of Denmark. Women with ovarian cysts are eligible for study inclusion. Exclusion criteria are age \< 18 years and unable to provide consent. We expect to include around 2.500 women in a period from ultimo 2019 to May 2022.

You may qualify if:

• women diagnosed with ovarian cysts
• age 18 or above
• understanding, speaking, and writing Danish

You may not qualify if:

• age \< 18
• unable to provide consent

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Claus Kim Høgdall

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Ovarian Cysts; Ovarian Neoplasms

Interventions

WAP Four-Disulfide Core Domain Protein 2

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Endocrine Gland Neoplasms; Neoplasms by Site; Genital Neoplasms, Female; Urogenital Neoplasms

Intervention Hierarchy (Ancestors)

Epididymal Secretory Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Claus Høgdall, Professor

  Gynecologic Clinic, Rigshospitalet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, DMSc

Study Record Dates

• First Submitted: November 1, 2019
• First Posted: December 6, 2019
• Study Start: January 1, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 6, 2025

Record last verified: 2025-04

Locations

DK (1)